MAUDE Adverse Event Report: KING SYSTEMS CORP. PEDIATRIC KING AIRWAY 2.5; SUPRAGLOTTIC AIRWAY

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2016

Event Type  malfunction  

Event Description

Medical product is mislabeled.The ambu corp.The pediatric king 2.5 supraglottic airway is mislabeled.There is a difference between the product label and the instructional insert.

• Brand Name: PEDIATRIC KING AIRWAY 2.5
• Type of Device: SUPRAGLOTTIC AIRWAY
• Manufacturer (Section D): KING SYSTEMS CORP.
• MDR Report Key: 5665964
• MDR Text Key: 45588959
• Report Number: MW5062364
• Device Sequence Number: 1
• Product Code: CAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1